FDA Approves Gemtesa (vibegron) Tablets for the Treatment of Patients with Overactive Bladder (OAB)
IRVINE, Calif.& BASEL, Switzerland--(BUSINESS WIRE)--Dec. 23, 2020-- Urovant Sciences (Nasdaq: UROV) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for once-daily 75 mg Gemtesa... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 23, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Kineret (anakinra) for the Treatment of Deficiency of IL-1 Receptor Antagonist (DIRA)
WALTHAM, Mass., Dec. 22, 2020 (GLOBE NEWSWIRE) -- Sobi™, an international biopharmaceutical company dedicated to rare diseases, announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 22, 2020 Category: Drugs & Pharmacology Source Type: news

Tagrisso Approved in the US for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Non-Small Cell Lung Cancer
21 December 2020 -- AstraZeneca’s Tagrisso (osimertinib) has been approved in the US for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 21, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Pediatric Indication for Xeomin (incobotulinumtoxina) for the Treatment of Chronic Sialorrhea
RALEIGH, N.C., December 21, 2020 -- Merz Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Xeomin (incobotulinumtoxinA) for the treatment of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 21, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Ebanga (ansuvimab-zykl) for the Treatment of Zaire Ebolavirus Infection
December 21, 2020 -- The U.S. Food and Drug Administration approved Ebanga (Ansuvimab-zykl), a human monoclonal antibody, for the treatment for Zaire ebolavirus (Ebolavirus) infection in adults and children. Ebanga blocks binding of the virus to the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 21, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer
BASEL, Switzerland, Dec. 18, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced that the U.S. Food and Drug Administration (FDA) has approved Orgovyx... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 18, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Supplemental New Drug Application for Takeda ’s Iclusig (ponatinib) for Adult Patients with Resistant or Intolerant Chronic-Phase CML
December 18, 2020 -- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Iclusig (ponatinib) for adult patients with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 18, 2020 Category: Drugs & Pharmacology Source Type: news

Karyopharm Announces FDA Approval of Xpovio (selinexor) as a Treatment for Patients with Multiple Myeloma After At Least One Prior Therapy
NEWTON, Mass., Dec. 18, 2020 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial stage pharmaceutical company pioneering novel cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 18, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Riabni (rituximab-arrx), a Biosimilar to Rituxan
THOUSAND OAKS, Calif., Dec. 17, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Riabni (rituximab-arrx), a biosimilar to Rituxan® (rituximab), for the treatment of adult... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 17, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves GSK ’s Benlysta as the First Medicine for Adult Patients with Active Lupus Nephritis in the US
17 December 2020 --  GlaxoSmithKline plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) has approved Benlysta (belimumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 17, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Margenza (margetuximab-cmkb) for Patients with Pretreated Metastatic HER2-Positive Breast Cancer
ROCKVILLE, MD, Dec. 16, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 16, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp
BUFFALO, N.Y., Dec. 15, 2020 (GLOBE NEWSWIRE) -- Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions,... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 15, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Genentech ’s Ocrevus (ocrelizumab) Shorter 2-Hour Infusion for Relapsing and Primary Progressive Multiple Sclerosis
South San Francisco, CA -- December 14, 2020 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved a shorter two-hour infusion time for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 14, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Saxenda (liraglutide) for the Treatment of Obesity in Adolescents Aged 12-17
PLAINSBORO, N.J., Dec. 4, 2020 /PRNewswire/ -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved an updated label for Saxenda® (liraglutide) injection 3 mg for use in the treatment of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 4, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Orladeyo (berotralstat) as the First Oral, Once-Daily Therapy to Prevent Attacks in Hereditary Angioedema Patients
RESEARCH TRIANGLE PARK, N.C., Dec. 03, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the U.S. Food and Drug Administration (FDA) has approved oral, once-daily Orladeyo (berotralstat) for prophylaxis to... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 3, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Gallium 68 PSMA-11 as the First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer
December 01, 2020 -- Today, the U.S. Food and Drug Administration approved Gallium 68 PSMA-11 (Ga 68 PSMA-11)– the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 1, 2020 Category: Drugs & Pharmacology Source Type: news

Genentech Announces FDA Approval of Xolair (omalizumab) for Adults with Nasal Polyps
South San Francisco, CA -- December 1, 2020 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 1, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Hetlioz (tasimelteon) for the Treatment of Nighttime Sleep Disturbances in Smith-Magenis Syndrome
WASHINGTON, Dec. 1, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved Hetlioz (tasimelteon) capsule and liquid formulations for the treatment of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 1, 2020 Category: Drugs & Pharmacology Source Type: news

Genentech Announces FDA Approval of Gavreto (pralsetinib) for People With Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancers
South San Francisco, CA -- December 1, 2020 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Gavreto™ (pralsetinib) for the treatment of adult... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 1, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency
BOSTON, Nov. 27, 2020 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq:RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, announced today that the U.S.... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 27, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma
NEW YORK, Nov. 25, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the“Company” or“Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel,... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 27, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 24, 2020-- Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 24, 2020 Category: Drugs & Pharmacology Source Type: news

Genentech Announces FDA Approval of Xofluza for the Prevention of Influenza Following Contact With an Infected Person
South San Francisco, CA -- November 23, 2020 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 23, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies
PALO ALTO, Calif., Nov. 20, 2020 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. Food and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 20, 2020 Category: Drugs & Pharmacology Source Type: news

Imfinzi Approved in the US for Less-Frequent, Fixed-Dose Use
20 November 2020 --  AstraZeneca’s Imfinzi (durvalumab) has been approved in the US for an additional dosing option, a 1,500mg fixed dose every four weeks, in the approved indications of unresectable Stage III non-small cell lung cancer... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 20, 2020 Category: Drugs & Pharmacology Source Type: news

Vimpat (lacosamide) Now Approved by FDA for Primary Generalized Tonic-Clonic Seizures and Expanded Pediatric Use for People Living with Epilepsy
ATLANTA, Nov. 17, 2020 /PRNewswire/ -- UCB, a global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Vimpat (lacosamide) CV as adjunctive therapy in the treatment of primary generalized... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 17, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Merck ’s Keytruda (pembrolizumab) in Combination With Chemotherapy for Patients With Locally Recurrent Unresectable or Metastatic Triple‑Negative Breast Cancer Whose Tumors Express PD-L1 (CPS ≥10)
KENILWORTH, N.J.--(BUSINESS WIRE) November 13, 2020 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, in... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 13, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) Tablets for Colonoscopy Preparation
BRAINTREE, Mass., Nov. 10, 2020 /PRNewswire/ -- Sebela Pharmaceuticals® today announces that the U.S. Food and Drug Administration (FDA) approved Sutab® (sodium sulfate, magnesium sulfate, and potassium chloride) tablets. Sutab, a... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 10, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients
PAOLI, Pa.,— (BUSINESS WIRE)— November 9, 2020– Sedor Pharmaceuticals, LLC (Sedor) today announced that the U.S. Food and Drug Administration (FDA) has approved Sesquient (fosphenytoin sodium for injection) for the treatment of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 9, 2020 Category: Drugs & Pharmacology Source Type: news

Brilinta Approved in the US to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack
6 November 2020 -- AstraZeneca’s Brilinta (ticagrelor) has been approved in the US to reduce the risk of stroke, a leading cause of disability and death worldwide, in patients with acute ischemic stroke (National Institutes of Health... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 6, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis
CARY, N.C., Nov. 02, 2020 (GLOBE NEWSWIRE) -- Chiesi USA, Inc., the U.S. affiliate of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), received U.S. Food and Drug Administration (FDA) approval of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 2, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Eysuvis (loteprednol etabonate) Ophthalmic Suspension for the Short-Term Treatment of the Signs and Symptoms of Dry Eye Disease
WATERTOWN, Mass.--(BUSINESS WIRE)--Oct. 27, 2020-- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 27, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Sklice (ivermectin) Lotion for Nonprescription Use to Treat Head Lice
October 27, 2020 -- Today, the U.S. Food and Drug Administration approved a lotion to treat head lice for nonprescription, or over-the-counter (OTC), use through a process called a prescription (Rx)-to-OTC switch. The FDA initially approved Sklice... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 27, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19
FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct. 22, 2020-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 22, 2020 Category: Drugs & Pharmacology Source Type: news

Genentech Announces Full FDA Approval for Venclexta Combinations for Acute Myeloid Leukemia
South San Francisco, CA -- October 16, 2020 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has granted full approval of Venclexta (venetoclax) in... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 16, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Expanded Indication for Merck ’s Keytruda (pembrolizumab) in Adult Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)
KENILWORTH, N.J.--(BUSINESS WIRE) October 15, 2020 -- Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for Keytruda, Merck’s... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 15, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) Antibody Cocktail for Ebola (Zaire Ebolavirus)
TARRYTOWN, N.Y., Oct. 14, 2020 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced today that the U.S. Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 14, 2020 Category: Drugs & Pharmacology Source Type: news

Harmony Biosciences Receives FDA Approval for Expanded Use of Wakix (pitolisant) for the Treatment Of Cataplexy in Adult Patients with Narcolepsy
PLYMOUTH MEETING, PA and CHICAGO, IL, October 13, 2020— Harmony Biosciences Holdings, Inc. ( " Harmony " ) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 13, 2020 Category: Drugs & Pharmacology Source Type: news

Alexion Receives FDA Approval for New Advanced Formulation of Ultomiris (ravulizumab-cwvz) with Significantly Reduced Infusion Time
BOSTON--(BUSINESS WIRE)--Oct. 12, 2020-- Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced the U.S. Food and Drug Administration (FDA) has approved Ultomiris (ravulizumab-cwvz) 100 mg/mL formulation for the treatment of adults with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 12, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) as the First and Only Immunotherapy Treatment for Previously Untreated Unresectable Malignant Pleural Mesothelioma
PRINCETON, N.J.--(BUSINESS WIRE) October 2, 2020 -- Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) 360 mg every three weeks plus Yervoy (ipilimumab) 1 mg/kg every six weeks (injections for intravenous use) was approved by... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - October 2, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Alkindi Sprinkle (hydrocortisone oral granules) for Pediatric Adrenocortical Insufficiency
DEER PARK, Ill., Sept. 29, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases, today announced that the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 30, 2020 Category: Drugs & Pharmacology Source Type: news

Simponi Aria (golimumab) Approved by the FDA for Active Polyarticular Juvenile Idiopathic Arthritis and Extension of Its Active Psoriatic Arthritis Indication in Patients 2 Years of Age and Older
HORSHAM, PA, September 30, 2020– The Janssen Pharmaceutical Companies of Johnson& Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved Simponi Aria (golimumab) for patients 2 years of age and older for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 30, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Bausch + Lomb Alaway Preservative Free (Ketotifen Fumarate) Ophthalmic Solution, 0.035%
LAVAL, QC and DEER PARK, Ill., Sept. 25, 2020 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) ( " Bausch Health " ), Bausch + Lomb, a leading global eye health business, and Eton Pharmaceuticals, Inc. (NASDAQ: ETON) today... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 28, 2020 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Approves Pfizer ’s Xeljanz (tofacitinib) for the Treatment of Active Polyarticular Course Juvenile Idiopathic Arthritis
NEW YORK--(BUSINESS WIRE) September 28, 2020 -- Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved Xeljanz® (tofacitinib) for the treatment of children and adolescents 2 years and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 28, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Fetroja (cefiderocol) for the Treatment of Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia
OSAKA, Japan& FLORHAM PARK, N.J.--(BUSINESS WIRE) September 28, 2020 --Shionogi& Co., Ltd. (hereafter“Shionogi”) today announces that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 28, 2020 Category: Drugs & Pharmacology Source Type: news